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General Information for the Safe Use of the Flexible HD Cysto-Urethroscope
Safety Precautions When Using the Flexible HD Cysto-Urethroscope
The Flexible HD Cysto-Urethroscope must be used according to the recognized medical rules and procedures of
endoscopy.
Note: The patient leakage current limit of the CF-applied parts may be exceeded if CF-applied parts (application on
heart) are used in combination with other BF-applied parts.
In this case, the patient leakage current can be reduced by using only CF-applied parts.
Note: The video endoscope does not offer any electric insulation against high frequency (HF) currents. Protection
against high frequency currents should be ensured through the use of correct HF instruments. Please read the
instructions for use in the instruction leaflet supplied with the HF-applied part for more information.
Note: The Flexible HD Cysto-Urethroscope is not intended to be inserted into the ureters. The Flexible HD Cysto-
Urethroscope is intended to be used for visualization of the ureteral orifice to aid in the placement and removal of
devices within the ureters.
Warnings and Cautions
Warning: Every time the Flexible HD Cysto-Urethroscope is used, you must first check that it, and any accessories
used in combination with it, is in perfect condition. A damaged Flexible HD Cysto-Urethroscope or damaged acces-
sories must not be used.
Warning: Combinations of medical devices can only be considered safe if:
• They are identified as such in the respective instruction manual.
• The intended purpose and the interface specifications of the devices used in combination permit this.
Pay careful attention to the instructions and interface specifications of medical devices used in combination.
Warning: The Flexible HD Cysto-Urethroscope is delivered non-sterile and must be cleaned and sterilized according
to validated reprocessing instructions before the initial use as well as before any further application.
Warning: Do not point the light beam of the Flexible HD Cysto-Urethroscope into the eyes. Looking into the light
beam may cause eye damage.
Warning: Only use accessories (guide probes, cleaning brushes, etc.) that are specifically intended for use with the
Flexible HD Cysto-Urethroscope and can be operated in line with generally-accepted technical standards and occu-
pational safety guidelines.
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